加校正因子的主成分自身对照法测定加替沙星滴眼液有关物质  

HPLC Method with Correction Factor for Determination of Related Substances in Gatifloxacin Ophthalmic

作　　者：崔开宇[1] 肖学成[1] 罗来春[1] CUI Kaiyu;XIAO Xuecheng;LUO Laichun(Hubei University of Chinese Medicine, Wuhan 43006)

机构地区：[1]湖北中医药大学,湖北武汉430065

出　　处：《湖北中医药大学学报》2018年第1期60-64,共5页Journal of Hubei University of Chinese Medicine

基　　金：湖北省知识创新专项(自然科学基金)(项目编号:2016CFB320)

摘　　要：目的建立加校正因子的主成分自身对照法测定加替沙星滴眼液有关物质的含量。方法采用ZORBAX Eclipse XDB-C18(4.6mm×250mm,5μm)为色谱柱;以1%三乙胺水溶液(用磷酸调节pH值至4.3)-乙腈(87:13)为流动相,柱温30℃,检测波长254nm,流速1.0mL/min。结果加替沙星与各杂质分离度良好,各杂质相对校正因子在0.6-1.3范围。结论以加校正因子的主成分自身对照法测定加替沙星滴眼液有关物质含量的方法简单可行,为加替沙星滴眼液拟定质量标准提供依据。Objective To establish a method of HPLC for the determination of matter in the gatifloxacin ophthalmic, and measuring the relative correction factors of related substances. Methods Formulations were analyzed by using a ZORBAX Eclipse XDB-C 18 column （ 4.6mm×250mm, 5μm ） with the 1 % triethylamine aqueous solution （ adjusted pH to 4.3 by phosphoric acid） - acetonitrile （87 ： 13 ） for the mobile phase, the column temperature was 30℃, the wavelength was 254nm for the detection, the flowing rate was 1.0mL/min. Results Gatifloxacin was separated well from the impurities, the relative calibration factors of impurities were between 0.6 ~1.3. Conclusion The HPLC method for the determination of matter in the gatifloxacin ophthalmic is accessible and feasible, the main component self-compare with correction factor provides theory basis for the quality standard of gatifloxacin ophthalmic.

关 键 词：加替沙星滴眼液 有关物质 校正因子 高效液相色谱 

分 类 号：R259[医药卫生—中西医结合]